Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States

Melanoma Clinical Trial

Official title:

Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199846
• Other study ID #: CA209-983
• Status: Completed
• Phase: N/A
• First received: June 23, 2017
• Last updated: February 5, 2018
• Start date: October 25, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: December 31, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults 18 years or older

• Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015

• Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date

• Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)

Exclusion Criteria:

• Physicians unwilling or unable to follow study instructions

• Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
United States	Local Institution	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of treatment patterns for advanced melanoma patients	Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy	Aproximately 6 months
Secondary	Distribution of prescribing patterns	Distribution of prescribing patterns by type of practice setting and melanoma patient volume	Approximately 16 months
Secondary	Distribution of Patient Age at index date	Patient Age at index date will be determined from Medical Records	at baseline
Secondary	Distribution of Patient's Sex at Index Date	Patient's sex will be determined from Medical Records	At Baseline
Secondary	Distribution of Comorbidities at index date	Comorbidities will be determined using the Charlson Comorbidity Index (CCI)	At Baseline
Secondary	Distribution of Healthcare Coverage type	Healthcare Coverage type will be determined using Medical Records	At Baseline
Secondary	Distribution of Diagnosis Date	Melanoma Diagnosis Date will be determined using medical records	At Baseline
Secondary	Distribution of Advanced Diagnosis Date	Date of advanced/ metastatic melanoma diagnosis will be determined using medical records	At Baseline
Secondary	Distribution of Age at Onset	Diagnosis date-Date of Birth	At Baseline
Secondary	Distribution of Disease stage at time of diagnosis	Disease stage at time of diagnosis will be determined using medical records	At Baseline
Secondary	Distribution of Disease stage at subsequent visits	Disease stage at subsequent visits will be determined using medical records	Approximately 16 months
Secondary	Distribution of ECOG status at Baseline	Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records	At Baseline
Secondary	Distribution of ECOG status at Last Visit	Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records	Approximately 16 months
Secondary	Distribution of Biomarker status at baseline	Biomarker status will be determined using Medical Records	at baseline
Secondary	Distribution of treatment-related adverse events	treatment-related adverse events will be determined using medical records	Approximately 16 months
Secondary	Distribution of Overall Survival (OS) from Advanced Diagnosis	Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation	Approximately 16 months
Secondary	Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis	Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation	Approximately 16 months
Secondary	Distribution of Overall Response Rate (ORR)		Approximately 16 months
Secondary	Distribution of Overall Survival (OS) from Index Date	Date of death minus index treatment start date, censoring for LTF or end of observation	Approximately 16 months
Secondary	Distribution of Progression-Free Survival (PFS) at Index Date	Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation	Approximately 16 months
Secondary	Distribution of melanoma related HCRU		Approximately 16 months

External Links

•   BMS Clinical Trial Information
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